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Not yet recruiting NCT07640295

Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations

Phase I / Phase II Interventional Metastatic Pancreatic Ductal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JAB-23E73 tablet，nab-paclitaxel，gemcitabine.
Who it may be relevant to
Registry conditions: Metastatic Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Phase Ib/III Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations

Overview

The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.

Detailed description

This is a phase Ib/III, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of pan-KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in treatment-naive participants with metastatic PDAC.

Phase Ib study：an open-label study, including dose escalation and backfill cohorts, with approximately 40-80 participants planned to be enrolled (including approximately 20-50 participants in the backfill cohort),Aiming to determine the recommended phase III dose \[RP3D\] within investigated patient population groups.

Phase III: Following confirmation of the efficacy and safety of JAB-23E73 in combination with the AG regimen in Phase Ib, a Phase III trial will be initiated to evaluate the efficacy and safety of JAB-23E73 plus AG versus AG alone for the treatment of metastatic PDAC.

Interventions

  • Drug JAB-23E73 tablet，nab-paclitaxel，gemcitabine
    Orally, intravenous (IV) infusion

Primary outcome measures

  • Dose limiting toxicities (DLT) [Time frame: Up to 28 days]
  • Adverse events.safety evaluation [Time frame: Up to approximately 3 years]
Secondary outcome measures (9)
  • ORR [Time frame: Up to approximately 3 years]
  • DOR [Time frame: Up to approximately 3 years]
  • TTR [Time frame: Up to approximately 3 years]
  • PFS [Time frame: Up to approximately 3 years]
  • DCR [Time frame: Up to approximately 3 years]
  • OS [Time frame: Up to approximately 3 years]
  • PK [Time frame: Up to approximately 3 years]
  • PK [Time frame: Up to approximately 3 years]
  • PK [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

1.Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.

3\. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).

5\. ECOG performance status score of 0 or 1. 6. Adequate organ function.

Exclusion criteria

  • Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
  • A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
  • Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS inhibitors, or other agents of the same class.
  • Primary central nervous system (CNS) tumors.
  • Women who are pregnant or breast-feeding.
  • Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 13 centers
  • Beijing Cancer Hospital — Beijing
  • Zhejiang Cancer Hospital — Hangzhou
  • Beijing Tsinghua Changgung Hospital — Beijing
  • Hunan Cancer Hospital — Changsha
  • Harbin Medical University Cancer Hospital — Harbin
  • Jiangsu Province Hospital — Nanjing
  • Shanghai Jiaotong University School of Medicine Ruijin Hospital — Shanghai
  • ShanXi Cancer Hospital — Taiyuan
  • … and 5 more centers

Identifiers

NCT: NCT07640295 · JAB-23E73-2001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗